FDA WARNING_LETTER - H. R. Beal & Sons - October 28, 2011

On November 22, 2011, the FDA issued a Warning Letter to H.R. Beals and Sons, Inc. following inspections on October 3 and October 28, 2011, at their seafood processing facility in Southwest Harbor, ME. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110).

The firm's ready-to-eat (RTE), refrigerated, vacuum-packed lobstermeat was deemed adulterated due to insanitary conditions. Specific violations included: 1. **Inadequate HACCP Plan:** The HACCP plan for lobster meat listed a critical limit for pathogenic bacterial survival that was not scientifically validated. The proposed critical limit and monitoring technique were not based on a scientific study to ensure adequate reduction of target pathogens. The FDA recommended conducting temperature distribution and heat penetration studies. 2. **Insufficient Sanitation Monitoring:** The firm failed to adequately monitor the safety of water used in contact with food. There was no documentation for maintenance schedules of the water treatment system used for cooking and cooling lobsters, nor to demonstrate the water was free of chemical contaminants.

The firm's October 4, 2011, response was deemed unacceptable regarding the HACCP plan. For sanitation, the FDA acknowledged the firm'